There are about 36633 clinical studies being (or have been) conducted in France. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Retrospective, non-randomized, observational, single-center longitudinal study at the University Rehabilitation Hospital of Grau du Roi CHU of Nîmes, France. From January 2012 to Janvier 2023 patients hospitalized for lower limb amputation, were extracted from the computer database of the motion analysis laboratory (2 baropodometric platforms, Zebris, Germany). All patients with lower limb amputations, unilateral or bilateral, walking with or without technical aids, were included regardless of the level (trans-femoral or trans-tibial). Only patients hospitalized in the locomotor rehabilitation department were included in the study. Patients who were not autonomous for walking and required a third person (human assistance) were not included. Finally, deceased patients were also excluded from the study population. Prior to data collection, all participants received a note of non-objection. The study was reported on the Health Data Hub, and data collection and analysis were performed according to the MR004 reference methodologies. Walking amputee patients hospitalized in the locomotor rehabilitation department benefited from a systematic gait assessment before discharge from hospital after rehabilitation and validation of the prosthesis. During the gait analysis, on baropodometric platforms, the software provides a number of parameters: spatiotemporal, pressure distribution, vertical component of the ground reaction force and trajectory of the center of pressure. All patients were recorded over a distance of ten meters including the two meters of acceleration and deceleration according to the validity of the TM-10 for a duration of two minutes. The parameters from the CoP trajectory are calculated from the coordinates calculated in the platform reference frame. A processing of these data will be specially developed within the service. Three key parameters of the COP have been retained: Lateral symmetry (LS; the left/right offset of the intersection point, where the "zero position" is equivalent to perfect symmetry), lateral variability (LV; the standard deviation of the intersection point in the lateral direction, where "zero" equals constant steps in terms of width between the legs), and anteroposterior variability (APV; the standard deviation of the intersection point in the anteroposterior direction, where "zero" equals constant strides while walking on the treadmill). These parameters, which allow for the assessment of continuous COP trajectories with multiple strides, reflect the overall movements of individuals throughout the gait cycle.
Weaning and extubation are essential steps for the management of critically ill patients when mechanical ventilation (MV) is no longer required. Extubation failure (EF) occurs in approximately 10-30% (1,2) of all patients meeting the readiness criteria and have tolerated a spontaneous breathing trial (SBT). EF is associated with prolonged MV, as well as increased morbidity and mortality (2). Therefore, the early identification of critically ill patients who are likely to experience EF is vital for improved outcomes. EF can result from different factors (respiratory, metabolic, neuromuscular), particularly cardiac factor, and can be caused by the inability of the respiratory muscle pump to tolerate increases in the cardiac and respiratory load (1,3). Respiratory drive represents the intensity of the neural stimulus to breathe. In mechanically ventilated patients, it can be abnormally low (i.e., suppressed or insufficient) or abnormally high (i.e., excessive), and thus result in excessively low or high inspiratory effort, leading to potential injury to the respiratory muscles (i.e., myotrauma) (4,5) or to the lungs. A high incidence of abnormal drive (low or high) may explain the high incidence of diaphragm dysfunction at time of separation from mechanical ventilation (6). Airway occlusion pressure (P0.1) is the drop in airway pressure (Paw) 100 milliseconds after the onset of inspiration during an end-expiratory occlusion of the airway (7). P0.1 measurement is not perceived by the patient and does not influence respiratory pattern. It is, in theory, a reliable measure of respiratory drive because the brevity of the occlusion explains that it is not affected by patient's response to the occlusion and it is independent of respiratory mechanics (8). P0.1 has also been correlated with inspiratory effort (9, 10) and it has been shown that in patients under assisted mechanical ventilation P0.1 might be able to detect potentially excessive inspiratory effort (11). P0.1 is a non-invasive measure and clinically available at bedside since currently nearly all modern ventilators provide a means of measuring it. Originally, a high P0.1 during a spontaneous breathing trial was associated with failure, suggesting that a high respiratory drive could predict weaning failure. However, only a few and old clinical studies investigated the association between P0.1 and extubation failure (EF) and were not conclusive (12,13). We hypothesized that patients with EF would have increased P0.1 values during spontaneous breathing trial (SBT). Therefore, the aims of our study will be to (1) to evaluate the ability of changes in P0.1 (Delta-P0.1) during SBT to predict EF and (2) to assess if Delta-P0.1 is an independent predictor of EF.
The goal of this interventional pathophysiological exploratory, cohort, prospective, with a 6-month follow-up study is to characterize phenotypic and functional alterations of PolyMorphonuclear Neutrophils as well as monocytes/macrophages and dendritic cells in blood samples from rheumatoid arthritis patients. Investigators will perform prospective characterization of these myeloid cells before and after treatment to assess how the functional status of PMNs/myeloid cells affects the response to anti-TNFα (tumor necrosis factor alpha) in rheumatoid arthritis. This will identify key immune components potentially involved in the activation and/or recruitment of PolyMorphonuclear Neutrophils (PMN) (and other myeloid cells) that may play a role in the pathogenesis of Rheumatoid Arthritis and may help predict the response to anti-TNFα agents, thus guiding the decision-making of therapeutic strategies.
Catheter ablation of atrial fibrillation (AF) or left atrial tachycardia (GAD) is usually performed in patients treated with vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs) that are increasingly used. In some cases, patients need to have an unfractionated heparin relay (UFH) for the procedure. There are no recommendations for adjusting UFH doses during an AOD/UFH relay. DOACs interfere with the biological assay of UFH which poses a problem of adaptation of UFH doses in pre- and intra-procedure. The aim of the study is to evaluate the interference of residual DOAC on the measurement of anticoagulant activity of UFH in pre- and intra-procedure of AF ablation or GAD.
Cataract is the world's leading cause of blindness, the treatment of which, exclusively surgical, offers excellent results in terms of visual recovery. It represents the most frequently performed surgery in France with more than 800,000 procedures each year. However, some patients develop postoperative ocular surface disease that can affect final visual acuity and quality of life. For example, dry eye disease, very common in the elderly, can be worsened by cataract surgery. The identification of ocular surface biomarkers predictive of the postoperative risk of ocular surface disease carries the promise of better personalized perioperative care. Conjunctival impression cytology represents a rapid, minimally invasive method of collecting conjunctival cells, which has proven its usefulness in the evaluation of diseases of the ocular surface. The aqueous humor is directly accessible at the beginning of the surgery. An approach combining ultra-high performance liquid chromatography coupled with high-resolution mass spectrometry on the cells of the ocular surface and on the aqueous humor could improve our understanding of the physiopathology of ocular surface disease following cataract surgery. This study will aim to 1) search for prognostic biomarkers of ocular surface disease after cataract surgery using a metabo-lipidomic approach 2) improve our understanding of the pathophysiological mechanisms involved.
The goal of this clinical trial is to precise the impact of menstrual cycle and physical activity on the hamstrings muscle function in healthy active women. The main question it aims to answer is : is there a moment of the menstrual cycle when the muscle is better able to recover from a strenuous exercise ? Three appointments will be conducted to evaluate the hamstring muscles at difference moments of the menstrual cycle. Echographic and maximal force production measures will be done. Researchers will compare these results with a group taking oral contraceptives.
Weaning of mechanical ventilation is an important phase of ICU (Intensive Care Unit) patient hospitalization. Patients have to pass a spontaneous breathing trial, can have a phase of pause with mechanical ventilation before extubation and then can be weaned of invasive mechanical ventilation. Spontaneous breathing trial can be performed with a T-Tube or with Pressure support without PEEP (End Expiratory Positive Pressure) . Duration of spontaneous breathing trial range from 30 minutes to 120 minutes. Some clinicians performed an arterial blood gases at the end of the spontaneous breathing trial but this practice is not really defined and clearly explained in recommendations. Patients can benefit of ventilation support after extubation like non invasive pressure support or high flow nasal canulae. The procedure can be very different from a center to another, especially for arterial blood gases at the end of spontaneous breathing trial. Our aim is to observe in a multicenter study the daily practice of weaning of mechanical ventilation especially for arterial blood gases.
The primary objective of this study is to: - Evaluate the safety and tolerability of AMG 305 in adult participants - Determine the optimal biologically active dose (OBD), at or below the maximum tolerated dose (MTD) with MTD 1 as the maximum tolerated starting dose and MTD 2 as the maximum tolerated target dose - Determine the recommended phase 2 dose (RP2D)
Therapeutic advances in oncology have transformed the prognosis of cancer patients, placing a significant number of them either in a context of recovery or in prolonged remission close to a chronic disease. Thus, the reconquest of a life after cancer becomes possible but raises many challenges for the patient, his entourage, the medical profession and our society. One of the major challenges is the detection and management of treatment side effects for all patients. In addition to the standard organic assessment (glycaemia, creatinine, liver test, blood count), we are mainly interested in muscle deconditioning and cognitive impairment, which are particularly disturbed in these populations. After the evaluation day, patients are referred to the most appropriate structures (Adapted physical activity, sports for health, and rehabilitation at Henry Gabriel Hospital). JUMP research is part of axis 2 of the 2021-2030 cancer plan: "Limiting sequelae and improving quality of life", through sheets 1 (research) / 6 (access and quality) / 7 (prevention). This leads to the concrete implementation on the territory of adapted care channels in the city: medical structure, physiotherapy, Adapted Physical Activity (APA) structures, associative structures; which makes it possible to develop and strengthen the city-hospital link. Finally, it allows the patient to take ownership and get involved in the project, allowing in the future to make them truly active in they care and to advise and motivate their peers. This study is non-interventional, it uses research on data that is already collected as part of conventional care, during the JUMP evaluation day. This study allows the investigators to constitute a cohort of patients to study different parameters related to the disease or to the treatments received. Our main objective in this study is to describe the muscular and neurocognitive impairment of post-cancer patients evaluated as part of the JUMP program.
The goal of this clinical trial is to evaluate the efficacy of tucatinib and capecitabine in combination with intrathecal trastuzumab on overall survival rate at 12 months in HER2-positive metastatic breast cancer (MBC) patients with proven leptomeningeal evolution and requiring intrathecal therapy.